EP1270023B1 - In vivo abbaubare metallische Gefä stütze - Google Patents

In vivo abbaubare metallische Gefä stütze Download PDF

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Publication number
EP1270023B1
EP1270023B1 EP02019905A EP02019905A EP1270023B1 EP 1270023 B1 EP1270023 B1 EP 1270023B1 EP 02019905 A EP02019905 A EP 02019905A EP 02019905 A EP02019905 A EP 02019905A EP 1270023 B1 EP1270023 B1 EP 1270023B1
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EP
European Patent Office
Prior art keywords
support according
vascular support
magnesium
lithium
vivo
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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EP02019905A
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English (en)
French (fr)
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EP1270023A2 (de
EP1270023A3 (de
EP1270023B2 (de
Inventor
Bernd Prof. Dr. Heublein
Gerd Prof. Dr. Hausdorf
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FISCHER, ALFONS
Hausdorf Jacqueline Yvonne
HEUBLEIN, EVA
Original Assignee
Meyer Jorg
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Application filed by Meyer Jorg filed Critical Meyer Jorg
Priority to EP05005740.5A priority Critical patent/EP1552856B1/de
Publication of EP1270023A2 publication Critical patent/EP1270023A2/de
Publication of EP1270023A3 publication Critical patent/EP1270023A3/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/042—Iron or iron alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel

Definitions

  • the present invention relates to a stent made of metallic Materials for use in human or animal Body.
  • Implants have been known for a long time.
  • the first implants were developed for orthopedic purposes, For example, screws and nails for fixing Bone fractures. These initially consisted of relatively simple Iron alloys under in vivo conditions to corrosion tended. The corrosion caused that in the immediate Near the bone metals were released as ions, which gives an undesirable stimulus to the growth of bone tissue have given. The bone has grown stronger than it is actually desired and required. This was damaged the healthy bone material.
  • metallic implants are in the field of vascular surgery and cardiology, angiology and radiology. These implants include, for example, endoluminal and stents for the treatment of lesions. These Supports serve z. B. for expansion and lumen maintenance of constricted vessels, starting from the vessel lumen with a Balloon catheter (balloon expandable) or self-expanding (self expanding) the vascular lumen on a correspondingly keep optimal inner diameter.
  • the implant is in itself only required until the diseased vessel by biological Repairs on their own power required Can permanently hold the diameter. This is in general about 4 weeks after implantation of the case.
  • the permanent whereabouts of a metallic implant is associated with some disadvantages.
  • the implant performs as a foreign body to local and possibly also systemic Reactions.
  • the self-regulation of the affected Vascular segment obstructed.
  • the constant (pulsatile) load of the metal can lead to fatigue fractures, what with large-lumen implants (eg closure systems such as umbrellas) can lead to new medical problems.
  • stents in smaller lumens (2.5 - 6 mm) produce in about 20% a re-stenosis (so-called in-stent stenosis), what in the high number of implants cumulative to an additional medical and economic burden.
  • vascular regions eg extracranial vessels, leg arteries
  • vascular obstruction or an induced vascular occlusion can be permanently deformed outside with the consequences of a renewed Vascular obstruction or an induced vascular occlusion.
  • Each permanent implant is additionally having problems in particular for younger patients, therefore, because a stay is inevitable for decades.
  • an orthopedic implant known to be a corrosion resistant metallic Body and a biodegradable, metallic intermediate layer identifies for the contact area to the bone.
  • This intermediate layer together with the main body forms a electrochemical cell and generates an electrical voltage, which promotes bone growth.
  • the Surface layer for example, made of silver alloys can exist, degraded. This leads to the desired effect that bone growth has a positive effect for so long will be as required and then after complete removal the surface coating of the electrical stimulus subsides.
  • biodegradable substances based on polymers are used in vascular surgery. Their mechanical properties on the one hand and the subsequent foreign body reaction during biodegradation, on the other hand, cause that they are unsuitable as a sole material for implantation are. Have metallic materials / alloys favorable mechanical properties (elasticity, ductility, Stability) at lower mass, which is for the application through thin-lumen guidance systems with transcutaneous procedure an important requirement.
  • vascular support to make available from biodegradablem material that also has advantageous mechanical properties.
  • the medical implant made of a metallic material which degradable by corrosion in vivo is primarily the mechanical advantages of metallic Materials.
  • the corrosive degradation of the implant within prevented by a material selection time scale on the other hand, that the negative long-term effects of the metallic Enter foreign body. It is biologically beneficial if the material is an alloy their main component Magnesium is.
  • the biological, mechanical and chemical properties can be positively influenced, if as a secondary component Manganese, cobalt, nickel, chromium, copper, cadmium, Lead, tin, thorium, zirconium, silver, gold, palladium, platinum, Rhenium, silicon, calcium, lithium, aluminum, zinc, Iron, carbon or sulfur is provided.
  • a material altogether is currently an alloy of magnesium with a Share of up to 40% lithium and iron addition preferred. A good corrosion especially at the beginning of the degradation period results in an alloy or a sintered metal about equal parts of zinc and iron.
  • Such magnesium alloys are e.g. under the terms AZ91D, AM50A and AE42 available.
  • the medical implant comes in several basic variants executed.
  • For a vascular support is as a basic body tubular structure provided with additional processing.
  • As a closure system eg, ductus botalli, congenital and acquired septal defects, arterio-venous shunt connections
  • a closure system eg, ductus botalli, congenital and acquired septal defects, arterio-venous shunt connections
  • the invention is also applicable in occluders as closure systems for cavity connections, Vessels or duct systems.
  • the implant is also advantageous to use the implant as a fastener or Support device for the temporary fixation of tissue parts in the form of implants or transplants.
  • the material thickness of the material in Depending on the composition of the material chosen is that the degradation or corrosion process in vivo between 5 days and 6 months, especially between 2 weeks and 8 weeks, essentially completed.
  • a stent according to the invention is made of a tubular Basic body of the metallic and subsequent processing manufactured. From the mechanical structure forth are such Stents, for example, from EP 0221570 B1 known, wherein However, the material is a corrosion-resistant stainless steel is.
  • the material is an alloy with the main component magnesium and optionally the minor constituents lithium, iron, Zinc and traces of nickel.
  • the magnesium alloy should be in the range of 50 - 98% magnesium, 0 - 40% lithium, 0 - 5% iron and less than 5% other metals are lying.
  • the wall thickness of the stent struts should after processing amount to between 50 and 100 microns.
  • the inventive stent is in itself known manner with a balloon catheter in a morbid Constricted blood vessel used and there dilated or as self-expanding stent released, leaving the blood vessel stops at the desired diameter.
  • One without Stent implantation remaining restenosis (Recoil) and / or Dilatation-induced tissue rupture becomes effective treated.
  • the Stent of intimal tissue covers and retains its supportive function initially at.
  • the blood vessel gets through tissue growth as a result of self - repair operations in the area of implanted stents a new inherent stability.
  • the vessel lumen is stabilized at an optimal level.
  • the Choice of alloy material along with the chosen one Wall thickness on the other hand cause the stent in the Wall of the blood vessel is gradually degraded and after about 4 - 12 weeks only in traces.
  • the on Page 2 described disadvantages of a permanent implant go lost.
  • An inventive closure system is from a metallic skeleton, on which a Rolechen is attached, made.
  • Schirmchen are known for example from the alloy MP35N or Nitinol.
  • Such closure systems become a closure used by defects in the heart septa.
  • the wall thickness of the metallic framework is around 500 mm.
  • the screen is folded in a conventional manner and released in the defect to be occluded.
  • the umbrella of the The body's own tissues are covered and preserved by this tissue growth a new inherent stability.
  • the choice of alloy material along with the tissue wall thickness leads to that the metallic framework within 4 weeks to a few months and only one year later is present in traces.
  • a coil according to the invention is made of a helical shape made of wound metallic material and the Spiral pre-bent.
  • the diameter of the primary winding is 0.1 - 1 mm, depending on the vessel to be closed.
  • Such spirals (coils) are known, for example Nitinol, platinum alloys or tungsten alloys.
  • the closure coil in itself known manner in a stretched state in a cardiac catheter introduced and through this to the occlusive Advanced vessel.
  • the spiral When released from the cardiac catheter the spiral returns to its old form and closes through her lumen and her thrombogenicity, through Dacron or other fibers can be increased to be closed Vessel.
  • the locking mechanism After thrombosis of the vessel and ingrowth of connective tissue receives the locking mechanism a new inherent stability.
  • the applied spiral becomes gradually degraded, so that after about a year the implanted Material is only present in traces.
  • Magnesium alloys have the advantage that by suitable Choice of other alloying components expected in vivo Degradation speed can be chosen very accurately. In addition, magnesium is physiologically very well tolerated.

Description

Die vorliegende Erfindung betrifft eine Gefäßstütze aus metallischen Werkstoffen zum Einsatz in dem menschlichen oder tierischen Körper.
Implantate sind grundsätzlich seit langem bekannt. Die ersten Implantate wurden zu orthopädischen Zwecken entwickelt, beispielsweise Schrauben und Nägel zum Fixieren von Knochenbrüchen. Diese bestanden zunächst aus relativ einfachen Eisenlegierungen, die unter in vivo-Bedingungen zu Korrosion neigten. Die Korrosion führte dazu, dass in unmittelbarer Nähe des Knochens Metalle als Ionen freigesetzt wurden, die einen unerwünschten Anreiz für das Wachstum des Knochengewebes gegeben haben. Der Knochen ist stärker gewachsen, als es eigentlich erwünscht und erforderlich ist. Hierdurch wurde das gesunde Knochenmaterial geschädigt.
Aus diesem Grund ist man bestrebt, metallische Implantate grundsätzlich aus möglichst korrosionsbeständigen Materialien zu fertigen. Hier sind derzeit hauptsächlich korrosionsbeständige Edelstähle, Tantal und Titan im Gebrauch. Diese Implantate bleiben nach der Implantierung als Fremdkörper präsent und werden als solche vom Organismus erkannt. Sie sind nur durch eine zweite Operation zu entfernen.
Außerdem sind metallische Implantate im Bereich der Gefäßchirurgie und der Kardiologie, Angiologie und Radiologie bekannt. Diese Implantate umfassen zum Beispiel endoluminale und Gefäßstützen (Stents) zur Behandlung von Läsionen. Diese Stützen dienen z. B. zur Aufweitung und Lumenerhaltung von verengten Gefäßen, indem sie vom Gefäßlumen ausgehend mit einem Ballonkatheter (balloon expandable) oder selbstexpandierend (self expanding) das Gefäßlumen auf einem entsprechend optimalen Innendurchmesser halten. Das Implantat ist an sich nur so lange erforderlich, bis das erkrankte Gefäß durch biologische Reparaturvorgänge aus eigener Kraft den erforderlichen Durchmesser dauerhaft halten kann. Dies ist im allgemeinen etwa 4 Wochen nach Implantation der Fall.
Der dauerhafte Verbleib eines metallischen Implantats ist jedoch mit einigen Nachteilen verbunden. Das Implantat führt als Fremdkörper zu lokalen und eventuell auch systemischen Reaktionen. Zusätzlich wird die Selbstregulation des betroffenen Gefäßsegments behindert. Die ständige (pulsatile) Belastung des Metalls kann zu Ermüdungsbrüchen führen, was bei großlumigen Implantaten (z. B. Verschlusssystemen wie Schirmchen) zu neuen medizinischen Problemen führen kann. Gefäßstützen in kleineren Lumina (2,5 - 6 mm) erzeugen in etwa 20% eine erneute Stenosierung (sogenannte In-Stent-Stenose), was bei der hohen Zahl der Implantate kumulativ zu einer zusätzlichen medizinischen und ökonomischen Belastung führt. In einigen Gefäßregionen (z. B. extrakranielle Gefäße, Beinarterien) kann die metallische Struktur durch Krafteinwirkung von außen dauerhaft verformt werden mit den Folgen einer erneuten Gefäßobstruktion bzw. eines induzierten Gefäßverschlusses. Jedes Dauerimplantat ist zusätzlich mit Problemen insbesondere für jüngere Patienten deshalb verbunden, weil ein Verbleiben für Jahrzehnte unausweichlich ist.
Vollkommen biologisch abbaubare Implantate sind bislang nur aus Kunststoffmaterialien bekannt, beispielsweise aus der DE 2502884 C2. Dort wird eine Beschichtung eines orthopädischen Implantats mit Polymethylmethacrylat offenbart, das biodegradabel ist. Andere Kunststoffmaterialien umfassen Polylactidund Polyglycolsäureester. Außerdem ist aus der EP 0006544 B1 ein biodegradables Keramikmaterial auf Basis von Calciumphosphat bekannt, das ebenfalls zur Beschichtung von metallischen Implantaten dient.
Schließlich ist aus der WO 81/02668 ein orthopädisches Implantat bekannt, das einen korrosionsbeständigen metallischen Grundkörper sowie eine biologisch abbaubare, metallische Zwischenschicht für den Kontaktbereich zum Knochen ausweist. Diese Zwischenschicht bildet zusammen mit dem Grundkörper eine elektrochemische Zelle und erzeugt eine elektrische Spannung, die das Knochenwachstum fördert. Gleichzeitig wird die Oberflächenschicht, die beispielsweise aus Silberlegierungen bestehen kann, abgebaut. Dies führt zu dem angestrebten Effekt, dass das Knochenwachstum so lange positiv beeinflusst wird, wie es erforderlich ist und dann nach vollständigem Abbau der Oberflächenbeschichtung der elektrische Reiz nachlässt.
Bisher bekannte biodegradable Substanzen auf Polymerbasis werden in der Gefäßchirurgie verwendet. Ihre mechanischen Eigenschaften einerseits und die nachfolgende Fremdkörperreaktion während der Biodegradation andererseits führen dazu, dass sie als alleiniges Material für eine Implantation ungeeignet sind. Metallische Werkstoffe/Legierungen besitzen günstige mechanische Eigenschaften (Elastizität, Verformbarkeit, Stabilität) bei geringerer Masse, was für die Applikation durch dünnlumige Führungssysteme bei transkutanem Vorgehen eine wichtige Voraussetzung darstellt.
Es ist daher Aufgabe der vorliegenden Erfindung, eine Gefäßstütze aus biodegradablem Material zur Verfügung zu stellen, die zugleich vorteilhafte mechanische Eigenschaften aufweist.
Diese Aufgabe wird durch Gefäßstützer mit den Merkmalen des Anspruchs 1 gelöst.
Weil das medizinische Implantat aus einem metallischen Werkstoff gefertigt ist, der durch Korrosion in vivo abbaubar ist, liegen primär die mechanischen Vorteile metallischer Werkstoffe vor. Der korrosive Abbau des Implantats innerhalb einer durch Materialwahl einstellbaren Zeitskala verhindert . andererseits, dass die negativen Langzeiteffekte des metallischen Fremdkörpers eintreten. Dabei ist es biologisch vorteilhaft, wenn der Werkstoff eine Legierung ist deren Hauptbestandteil Magnesium ist.
Die biologischen, mechanischen und chemischen Eigenschaften der Werkstoffe sind positiv beeinflussbar, wenn als Nebenbestandteil Mangan, Kobalt, Nickel, Chrom, Kupfer, Cadmium, Blei, Zinn, Thorium, Zirkonium, Silber, Gold, Palladium, Platin, Rhenium, Silicium, Calcium, Lithium, Aluminium, Zink, Eisen, Kohlenstoff oder Schwefel vorgesehen ist. Als Material wird insgesamt derzeit eine Legierung aus Magnesium mit einem Anteil von bis zu 40% Lithium sowie Eisenzusatz bevorzugt. Eine besonders zu Beginn der Degradationszeit gute Korrosion ergibt sich bei einer Legierung oder einem Sintermetall aus etwa gleichen Teilen Zink und Eisen.
Vorteilhafte Abbauzeiten haben sich weiter ergeben bei Werkstoffen mit dem Hauptbestandteil Magnesium und entweder
  • - 0 - 40% Lithium, 0 - 5% Eisen und unter 5% andere Metalle oder seltene Erden;
  • - 2 - 5% Aluminium, 0 - 12% Lithium und 1 - 4% seltene Erden, insbesondere Cer, Lanthan, Neodym und/oder Praseodym,
  • - 6 - 12% Lithium, 2% Aluminium und 1% seltene Erden,
  • - 0 - 8% Lithium, 2 - 4% Aluminium und 1 - 2 % seltene Erden,
  • - 8,5 - 9,5% Aluminium, 0,15% - 0,4% Mangan, 0,45 - 0,9% Zink
  • - 4,5 - 5,3% Aluminium, 0,28% - 0,5% Mangan oder
  • - 30 - 40% Lithium und 0 - 5% andere Metalle und/oder seltene Erden enthält.
    • Derartige Magnesiumlegierungen sind z.B. unter den Bezeichnungen AZ91D, AM50A und AE42 verfügbar.
    Das medizinische Implantat wird in mehreren Grundvarianten ausgeführt. Für eine Gefäßstütze ist als Grundkörper ein rohrförmiger Aufbau mit zusätzlicher Bearbeitung vorgesehen. Als Verschlusssystem (z. B. Ductus Botalli, angeborene und erworbene Septumdefekte, arterio-venöse Shuntverbindungen) sind passiv und/oder aktiv entfaltbare Schirmformen, Spiralen oder komplexe Körper vorteilhaft. Die Erfindung ist auch anwendbar bei Okkludern als Verschlusssysteme für Hohlraumverbindungen, Gefäße oder Gangsysteme.
    Es ist außerdem vorteilhaft, das Implantat als Befestigungsoder Stützvorrichtung für die temporäre Fixierung von Gewebeteilen in Form von Implantaten oder Transplantaten vorzusehen.
    Zur Einstellung der Korrosionsgeschwindigkeit des Werkstoffs ist von Vorteil, wenn die Materialstärke des Werkstoffs in Abhängigkeit von der Zusammensetzung des Werkstoffs so gewählt ist, dass der Abbau- oder Korrosionsvorgang in vivo zwischen 5 Tagen und 6 Monaten, insbesondere zwischen 2 Wochen und 8 Wochen, im wesentlichen abgeschlossen ist.
    Hierbei wird erreicht, dass nach einem Anwachsen des Gewebeimplantats die dann nicht mehr benötigte Fixiervorrichtung verschwindet.
    Im folgenden werden verschiedene Ausführungsbeispiele der vorliegenden Erfindung gegeben.
    Beispiel 1: Gefäßstütze
    Ein erfindungsgemäßer Stent wird aus einem rohrförmigen Grundkörper des metallischen und nachfolgender Bearbeitung gefertigt. Vom mechanischen Aufbau her sind derartige Stents beispielsweise aus der EP 0221570 B1 bekannt, wobei das Material jedoch ein korrosionsbeständiger Edelstahl ist.
    Bei dem erfindungsgemäßen Stent nach diesem Beispiel ist das Material eine Legierung mit dem Hauptbestandteil Magnesium und gegebenenfalls den Nebenbestandteilen Lithium, Eisen, Zink und Spuren von Nickel. Die prozentuale Zusammensetzung der Magnesiumlegierung soll etwa im Bereich von 50 - 98% Magnesium, 0 - 40% Lithium, 0 - 5% Eisen und unter 5% andere Metalle liegen. Die Wandstärke der Stentstreben soll nach der Bearbeitung zwischen 50 und 100 µm betragen.
    In der Praxis wird der erfindungsgemäße Stent in an sich bekannter Weise mit einem Ballonkatheter in ein krankhaft verengtes Blutgefäß eingesetzt und dort dilatiert oder als selbstexpandierender Stent freigesetzt, wobei er das Blutgefäß auf dem gewünschten Durchmesser hält. Eine ohne Stent-Implantation verbleibende Restenose (Recoil) und/oder ein durch die Dilatation induzierter Geweberiss werden wirkungsvoll behandelt. Innerhalb von 2 - 4 Wochen wird der Stent von Intimagewebe überdeckt und behält seine Stützfunktion zunächst bei. Das Blutgefäß erhält durch Gewebewachstum infolge von Eigenreparaturvorgängen im Bereich des implantierten Stents eine neue Eigenstabilität. Das Gefäßlumen wird auf einem optimalen Niveau stabilisiert. Die Wahl des Legierungsmaterials zusammen mit der gewählten Wandstärke führen andererseits dazu, dass der Stent in der Wandung des Blutgefäßes allmählich abgebaut wird und nach etwa 4 - 12 Wochen nur noch in Spuren vorliegt. Die auf Seite 2 geschilderten Nachteile eines Dauerimplantats gehen verloren.
    Beispiel 2: Verschlusssystem
    Ein erfindungsgemäßes Verschlusssystem (Schirmchen) wird aus einem metallischen Skelett, an dem ein Kunststoffschirmchen befestigt ist, gefertigt. Derartige Schirmchen sind bekannt beispielsweise aus der Legierung MP35N oder Nitinol. Derartige Verschlusssysteme werden zum Verschluss von Defekten in den Herzscheidewänden verwendet. Die Wandstärke des metallischen Gerüstes beträgt um 500 mm. In der Praxis wird das Schirmchen in an sich bekannter Weise zusammengefaltet und in dem zu verschließenden Defekt freigesetzt. Innerhalb von 3 - 4 Wochen wird das Schirmchen vom körpereigenen Gewebe bedeckt und erhält durch dieses Gewebewachstum eine neue Eigenstabilität. Die Wahl des Legierungsmaterials zusammen mit der Gewebewandstärke führt dazu, dass das metallische Gerüst innerhalb von 4 Wochen bis einigen Monaten abgebaut wird und nach einem Jahr nur noch in Spuren vorliegt. Der Kunststoffanteil des Schirmchens bleibt erhalten, was aufgrund der Flexibilität des Materials unkritisch ist. Der Abbau des metallischen Anteils hat gegenüber den bekannten Schirmchen den Vorteil, dass auch bei unvorhergesehenen Belastungen z.B. bei Verkehrsunfällen keine Gefahr des Durchstoßens von Gefäßwandungen mehr besteht. Dabei wird der erfindungsgemäße Vorteil bereits erreicht, wenn zunächst durch die Degradation eine mechanische Instabilität des Gerüsts entsteht.
    Beispiel 3: Spirale zum Verschließen von Gefäßen (Okkluder)
    Eine erfindungsgemäße Spirale (Coil) wird aus einem in Helixform gewickelten metallischen Material gefertigt und die Spirale vorgebogen. Der Durchmesser der Primärwicklung beträgt 0,1 - 1 mm, je nach dem zu verschließenden Gefäß. Derartige Spiralen (Coils) sind bekannt, beispielsweise aus Nitinol, Platinlegierungen oder Wolframlegierungen.
    In der Praxis wird die Verschlussspirale (Coil) in an sich bekannter Weise in gestrecktem Zustand in einen Herzkatheter eingeführt und durch diesen bis zu dem zu verschließenden Gefäß vorgeschoben. Bei der Freisetzung aus dem Herzkatheter nimmt die Spirale wieder ihre alte Form an und verschließt durch ihr Lumen und ihre Thrombogenität, die durch Dacron oder andere Fasern erhöht werden kann, das zu verschließende Gefäß. Nach Thrombosierung des Gefäßes und Einwachsen von Bindegewebe erhält der Verschlussmechanismus eine neue Eigenstabilität. Die applizierte Spirale wird allmählich abgebaut, so dass nach etwa einem Jahr das implantierte Material nur noch in Spuren vorliegt.
    Die insoweit genannten Ausführungsbeispiele lassen sich mit Magnesiumlegierungen fertigen. Toxische Wirkungen der Materialien bei den zu erwartenden Konzentrationen sind nicht bekannt.
    Magnesiumlegierungen haben den Vorteil, dass durch geeignete Wahl der übrigen Legierungsbestandteile die in vivo zu erwartende Abbaugeschwindigkeit sehr genau gewählt werden kann. Außerdem ist Magnesium physiologisch sehr gut verträglich.

    Claims (12)

    1. Gefäßstütze aus einem durch Korrosion in vivo abbaubaren metallischen Werkstoff, dadurch gekennzeichnet, dass der Werkstoff eine Legierung ist, deren Hauptbestandteil Magnesium ist.
    2. Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, dass der Werkstoff 79 - 97% Magnesium, 2 - 5% Aluminium, 0 - 12% Lithium und 1 - 4% seltene Erden, insbesondere Cer, Lanthan, Neodym und/oder Praseodym enthält.
    3. Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, dass der Werkstoff 85 - 91% Magnesium, 6 - 12% Lithium, 2% Aluminium und 1% seltene Erden enthält.
    4. Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, dass der Werkstoff 86 - 97% Magnesium, 0 - 8% Lithium, 2 - 4% Aluminium und 1 - 2 % seltene Erden enthält.
    5. Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, dass der Werkstoff 8,5 - 9,5% Aluminium, 0,15% - 0,4% Mangan, 0,45 - 0,9% Zink und den Rest zu 100% Magnesium enthält.
    6. Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, dass der Werkstoff 4,5 - 5,3% Aluminium, 0,28% - 0,5% Mangan und den Rest zu 100% Magnesium enthält.
    7. Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, dass der Werkstoff 55 - 65% Magnesium, 30 - 40% Lithium und 0 - 5% andere Metalle und/oder seltene Erden enthält.
    8. Gefäßstütze nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Implantat einen im wesentlichen rohrförmigen Grundkörper aufweist.
    9. Gefäßstütze nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Materialstärke des Werkstoffs in Abhängigkeit von der Zusammensetzung des Werkstoffs so gewählt ist, dass der Abbau- oder Korrosionsvorgang in vivo im Bereich von 5 Tagen bis zu 6 Monaten, insbesondere zwischen 2 Wochen und 8 Wochen im wesentlichen abgeschlossen ist.
    10. Gefäßstütze nach einem der vorhergehenden Ansprüche 1 bis 8, dadurch gekennzeichnet, dass die Materialstärke des Werkstoffs in Abhängigkeit von der Zusammensetzung des Werkstoffs so gewählt ist, dass der Abbau- oder Korrosionsvorgang in vivo im Bereich von 6 Monaten bis zu 10 Jahren, insbesondere zwischen 1 Jahr und 5 Jahren im wesentlichen abgeschlossen ist.
    11. Gefäßstütze nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Abbau- oder Korrosionsvorgang in vivo zunächst zu einer mechanischen Instabilität führt, bevor der Abbauvorgang im wesentlichen abgeschlossen ist.
    12. Gefäßstütze nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Werkstoff als Nebenbestandteil ein oder mehrere Elemente aus der Gruppe enthält, die folgendes umfasst: Mn, Co, Ni, Cr, Cu, Pb, Sn, Th, Zr, Ag, Au, Pd, Pt, Re, Si, Ca, Li, Al, Zn, Fe, C, S.
    EP02019905A 1997-07-18 1998-07-17 In vivo abbaubare metallische Gefäßstütze Expired - Lifetime EP1270023B2 (de)

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    US8840660B2 (en) 2006-01-05 2014-09-23 Boston Scientific Scimed, Inc. Bioerodible endoprostheses and methods of making the same
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    US7985252B2 (en) 2008-07-30 2011-07-26 Boston Scientific Scimed, Inc. Bioerodible endoprosthesis
    US8382824B2 (en) 2008-10-03 2013-02-26 Boston Scientific Scimed, Inc. Medical implant having NANO-crystal grains with barrier layers of metal nitrides or fluorides
    US8267992B2 (en) 2009-03-02 2012-09-18 Boston Scientific Scimed, Inc. Self-buffering medical implants
    EP2260884A1 (de) 2009-06-09 2010-12-15 Heller, Jorg Implantatsystem mit einem temporären Implantat und Verfahren zum Beeinflussung der Korrosionsrate eines Implantates
    EP2260883A2 (de) 2009-06-09 2010-12-15 Heller, Jorg Verfahren und Vorrichtung zur Beeinflussung und Steuerung der Korrosionsrate von Implantaten
    US8668732B2 (en) 2010-03-23 2014-03-11 Boston Scientific Scimed, Inc. Surface treated bioerodible metal endoprostheses

    Also Published As

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    PT1270023E (pt) 2005-10-31
    DK1270023T3 (da) 2005-09-05
    EP0923389A2 (de) 1999-06-23
    EP1270023A2 (de) 2003-01-02
    ATE297767T1 (de) 2005-07-15
    EP1552856B1 (de) 2015-10-07
    DE59812873D1 (de) 2005-07-21
    ATE236667T1 (de) 2003-04-15
    EP0923389A3 (de) 2002-08-28
    IL129065A (en) 2006-04-10
    WO1999003515A2 (de) 1999-01-28
    AU9154198A (en) 1999-02-10
    JP2009297537A (ja) 2009-12-24
    IL129065A0 (en) 2000-02-17
    JP5352776B2 (ja) 2013-11-27
    US20110301694A1 (en) 2011-12-08
    ES2243635T3 (es) 2005-12-01
    US7879367B2 (en) 2011-02-01
    WO1999003515A3 (de) 1999-08-05
    IL172424A (en) 2008-08-07
    US20110251669A1 (en) 2011-10-13
    JP2011031063A (ja) 2011-02-17
    EP1270023A3 (de) 2003-12-17
    US20020004060A1 (en) 2002-01-10
    JP2001511049A (ja) 2001-08-07
    EP1552856A1 (de) 2005-07-13
    ES2200368T3 (es) 2004-03-01
    EP1270023B2 (de) 2012-04-11
    US8771751B2 (en) 2014-07-08
    DE19731021A1 (de) 1999-01-21
    DE59807846D1 (de) 2003-05-15
    EP0923389B1 (de) 2003-04-09

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